The present invention relates generally to surgical implants and suture assemblies for securing implants to patients. More specifically, the present invention relates to surgically implantable devices for the repair of hernias and surgical incisions, reconstructive surgery, prosthetic medical devices and suture assemblies attached thereto.
The structural integrity of a membrane or muscle may be compromised by a rupture or split resulting from physical strain combined with an inherent weakness of the tissue. Alternatively, a congenital abnormality may leave an opening in a membrane that would otherwise be closed during normal development. When damage or abnormalities of this nature occur to the abdominal wall, it provides an opportunity for an internal organ or other anatomical feature to protrude through the ruptured membrane as a hernia. The patient""s symptoms can range from mild discomfort to acute pain, and the protruding organ itself can be compressed or constricted. The organ or that part thereof that protrudes through the body cavity wall can then undergo progressive deterioration. In the severest cases, the organ could become permanently damaged, with chronic health consequences for the patient. In the short term, a total or partial blockage of an organ such as an intestine can have an immediate impact on the general health of the patient.
A hernia, i.e. the protrusion of an organ through a tissue, may occur anywhere in the body. When in the lower abdominal area, it often involves penetration of the intestine into or through the abdominal wall. A frequently encountered hernia occurs in the region of the superficial inguinal ring of the groin region. When the intestine protrudes through the inguinal opening in the abdominal cavity wall, one has a direct or indirect inguinal hernia. A femoral hernia results from the intestine protruding through the abdominal wall in the region of the femoral ring.
Temporary relief from the symptoms of a hernia can be obtained by the patient wearing a truss device that applies external pressure against the abdomen in the region of the organ protrusion. This well-known and long-established treatment rarely, if ever, provides other than temporary relief from pain and more obvious discomfiture. Permanent relief typically requires invasive surgery to return the offending organ to its original and correct position, followed by the repair and reinforcement of the split or weakness in the abdominal wall.
The surgical procedure may be under local or general anathesia. Commonly, a large incision up to six inches long is made in the lower abdomen and the protruding organ, such as a region of the intestine, is retracted back out of the rupture and into the body cavity. The break in the body wall tissues can then be closed by suturing across the split or by pulling the sides of the split together, similar to the tying of a sack. The newly closed, but still weakened area of the body wall, may be reinforced by covering the repair with a flexible mesh material that is sutured or stapled into position. Still, the repaired hernia represents a mechanically weaker region of the internal abdominal wall. Accordingly, a xe2x80x9crecurrent herniaxe2x80x9d can subsequently occur due to the breakdown of the repaired injury. An additional possible complication of this procedure is the occurrence of an xe2x80x9cincision herniaxe2x80x9d where the surgical entry into the abdomen has reduced the integrity of the abdominal wall, and allowed another hernia to later develop at that site.
Conventional surgical procedures for hernia repair are traumatic for the patient. Not only does the surgical incision disrupt still further the mechanical integrity of the abdominal wall, but general surgical procedures may also lead to post-operative complications, including infection, hemorrhage, and damage to the underlying organs, musculature and nerves, that are associated with all invasive surgery.
The preferred techniques for hernia repair, therefore, employ laparoscopy and endoscopy, and so avoid many of the disadvantages of more invasive techniques. In both laparoscopy and endoscopy, the necessary surgical devices and implants are introduced into the body cavity by small incisions that typically are only wide enough to allow narrow tubes to penetrate through the abdominal wall into the interior of the body cavity. The surgery is performed remotely by directing the actions of the instruments from outside the body, while observing the surgical site with optical probes also inserted into the patient. Laparoscopic and endoscopic surgery speeds the recovery of the patient, who also suffers much less overall discomfort. Such remotely conducted surgical procedures, however, generate practical difficulties for the surgeon. It is generally more difficult to insert a flexible mesh material through the small incision and position the material over the site of the hernia. Difficulties are also met when the surgeon attempts to suture the mesh material into position. The suture threads are long and have a tendency to become entangled. Further, the confined nature of a laparoscopic or endoscopic surgical site that has not been fully opened to the exterior hinders the rapid and precise placement of the sutures on the mesh material, once the latter has been positioned against the abdominal wall.
This compares with the attachment of scalp patches to the exterior surface of the head of a patient, wherein the sutures placed around the circumference of the patch may be a single suture thread interlaced between the patch and the scalp, as disclosed in Dick et al. (U.S. Pat. No. 3,914,801), and Connelly and Villani (U.S. Pat. No. 3,842,439), or by suture threads preinserted into the scalp, before attachment of the patch as disclosed by Bauman (U.S. Pat. No. 3,553,737). These disclosures, however, concern patches externally applied and require sutures to be applied after positioning a patch, or by applying sutures on the recipient patient. The external application of the patch greatly eases the technical burden of the surgeon.
A variety of methods and devices have been proposed to facilitate the securing of an implantable mesh material onto a laparoscopic or endoscopic instrument, and for positioning the mesh material within the body cavity. U.S. Pat. No. 5,333,624 to Tovey describes a device and procedure that attaches a surgical implant to an apparatus for positioning the implant within the body. U.S. Pat. No. 5,916,225 to Kugel discloses a patch with a pocket, whereby the surgeon may insert a finger into the pocket and maneuver the patch over the site of the rupture. Once in position over the herniated region, however, the surgeon still faces the problem of laparoscopically suturing the implant securely over the hernia.
In laparoscopic or endoscopic surgery, a surgeon must introduce suture threads into the body cavity through a narrow incision, position the threads against and through the implanted mesh material and tie the sutures within the confines of the body cavity. Alternatively, suture threads are prepositioned on the implant, but then have to be located and gripped by the surgical tools before the threads are passed through the abdominal wall for tying. Prepositioned suture threads, however, are difficult to locate once the implant has been placed against the site of the hernia, and long loose threads are likely to become entangled, or encounter other obstructions, thereby preventing the efficient manipulation of the threads. These problems are further exacerbated by the size of the implant and the number of sutures necessary to secure the patch. Problems similar to those of laparoscopic and endoscopic application of an implantable mesh material for the repair of a hernia may also be encountered when other implanted devices must be internally secured to a patient by minimally invasive surgical procedures.
There is, therefore, a need for a simple means of placing suture threads adjacent to the abdominal body wall and at predetermined positions so that the surgeon will be able to readily locate the suture threads for retraction through the abdominal wall. What is further needed is a method and devices for locating a suture thread in the body that does not demand extensive probing and minimizes the period of surgery.
Further, there remains a need for attaching a suture thread to an implantable device, such as an implantable patch for the repair of a hernia. A surgeon using laparoscopic and endoscopic procedures can then position sutures at predetermined sites, grasp the sutures, and pull them through a tissue for tying, without the threads entangling or otherwise resisting the surgeons actions. The present invention, therefore, is intended to provide surgically implantable devices or other prosthetic devices that have novel suturing assemblies thereon to facilitate both the grasping of the suture threads and their use without tangling and impeding securing an implantable device to the patient.
These and other objects and advantages of the invention will become fully apparent from the description and claims that follow or may be learned by the practice of the invention.
Briefly described, the present invention comprises a surgically implantable device with attached sutures and a method of applying the implant to a patient. In one aspect of the present invention, the surgically implantable device comprises a body and at least one suture thread mounted to the body and a pull-tab attached to the thread. The proximal end of the suture thread is attached to the body, and a distal region is removably attached to the body.
Another aspect of the present invention relates to a surgically implantable device such as a surgically implantable patch for the repair of a hernia, and at least one suture assembly attached to the patch. The suture assembly comprises at least one suture housing and at least one suture thread that has a proximal end attached to the patch and a distal region removably disposed within the suture housing. A pull-tab is attached to the suture thread.
Yet another aspect of the present invention relates to a suture assembly that may be attached to a surgical implant for securing the device to a patient. The surgical assembly comprises a suture thread, a pull-tab attached to the suture thread, and a suture housing. The suture thread has a proximal end attached to a surgical implant and a distal region, wherein the distal end of the suture thread is detachably attached to a surgically implantable device.
Still another aspect of the present invention relates to a method of surgically attaching a surgical implant to a patient, comprising the steps of selecting a surgical implant that has at least one suture thread attached thereon, inserting the surgical device through an incision in the abdominal wall and into the body cavity of a patient, placing the device so as to place the suture assembly adjacent to the abdominal wall, acquiring the suture thread by means of a pull-tab located thereon, pulling the suture through the abdominal wall and securing at least one of the suture threads to the patient.
The present invention addresses the need of a surgeon to readily locate suture threads that are attached to a surgically implantable device before implantation into the patient. The present invention further addresses the need to grasp the suture threads and pass them through body tissues by laparoscopic or endoscopic surgery, without the predisposed suture threads entangling or otherwise resisting the surgical procedure. The present invention addresses these needs by removably confining suture threads to an implantable device while the proximal ends of the threads are securely fixed to the implanted device. The present invention further includes novel pull-tabs that allow the grasping of a suture thread and its detachment from the implantable device, while one end of each thread remains attached to the implantable device.
Additional objects, features, and advantages of the invention will become more apparent upon review of the detailed description set forth below when taken in conjunction with the accompanying drawing figures, which are briefly described as follows.